Medical Innovation Bills On Fast Track In Congress, But Some Barriers Remain
With an all-Republican House, Senate and administration lined up to lead the government following the 2016 elections, the path is clear for passage of a set of FDA reforms to ease device approvals embedded in a combined House 'Cures' and Senate medical innovation package. It could even happen over the upcoming lame-duck session, before the new administration and Congress take over. But controversy around price-gouging by drug firms still could stymie quick Cures bill passage, an industry attorney predicts. Meanwhile, medtech industry groups plan to seize on the Trump victory as a means to achieve permanent device tax repeal.
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Following the Nov. 8 elections, the power of the incumbency prevailed, and there were few election-related changes to key committee assignments in the Senate Finance Committee, which oversees Medicare, health and tax policy, and in the Senate Health, Education, Labor and Pensions (HELP) panel, which oversees FDA and other health policy issues. Some members may choose to switch assignments once the next Congress convenes in January 2017, however.
Following the Nov. 8 election, many members of the House Ways and Means Committee, which has jurisdiction over Medicare and taxes, and the House Energy and Commerce, which oversees FDA and other health matters, kept their seats. A handful of committee members won't return due to retirement, Senate races and a few election losses. Some members may choose to switch assignments once the next Congress convenes in January 2017, however
Patient advocacy groups unanimously thanked FDA and industry for including patient engagement and real-world evidence elements in the new user-fee deal during a Nov. 2 meeting. RWE was initially a point of disagreement during negotiations between FDA and industry, but industry cautiously supported pilot funding.